Cell Block Immunohistochemistry in Effusion Cytology

NCT ID: NCT04279327

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-01-31

Brief Summary

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Cytology is usually the first step in investigating serous effusions, to either detect or exclude an underlying malignancy. This study will try to answer the need for improved diagnostic yield of cytologic examination by cell block technique and immunohistochemical testing of three markers which are EZH2, Claudin-4 and MOC-31.

Detailed Description

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This is a prospective study that will be conducted at the pathology lab of Assiut University Hospital. The study will include effusion specimens (pleural, peritoneal \& pericardial) and the aspirated fluid will be examined for physical characters e.g. color and appearance.

The sample will be divided into 2 equal parts: one for conventional smear preparation, and the other for cell block. A minimum of 2 thin smears will be prepared and stained with Papanicolou stain.

Cell block sections of 4-6 μ thickness will be prepared and stained with the hematoxylin and eosin stain (H\&E).

For immunohistochemistry, cell blocks will be used. Expression of claudin 4, EZH2, and MOC-31 will be evaluated in benign and malignant cells by using immunoperoxidase technique.

Conditions

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Effusion Pleural Ascites Pericardial Effusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cases

cytology positive for malignancy

No interventions assigned to this group

controls

cytology negative for malignancy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aliaa Elhosainy Mohammad Mahmoud

Associate Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aliaa EM Mahmoud, MSc

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aliaa EM Mahmoud, MSc

Role: CONTACT

+201007508736

References

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Sundling KE, Cibas ES. Ancillary studies in pleural, pericardial, and peritoneal effusion cytology. Cancer Cytopathol. 2018 Aug;126 Suppl 8:590-598. doi: 10.1002/cncy.22021.

Reference Type BACKGROUND
PMID: 30156768 (View on PubMed)

Other Identifiers

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immuno-cytology001

Identifier Type: -

Identifier Source: org_study_id

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